Certificate to Pharmaceutical Product (CPP)

The Certificate to a Pharmaceutical Product (CPP) is an official FDA certificate required by many countries for drug import registration. LMG assists drug manufacturers with CPP applications to FDA.

Drug RegistrationRequired for ExportOfficial FDA Certificate

CPP Certificate Services

LMG prepares and submits CPP applications to FDA — An internationally recognized document that confirms a pharmaceutical product’s marketing status and regulatory compliance.

CPP Application to FDA

Complete preparation and submission of your Certificate to Pharmaceutical Product (CPP) application to FDA. The CPP confirms your product's U.S. marketing status and regulatory compliance, facilitating export and foreign market registration.

Drug Registration & Listing

Prerequisites for CPP issuance: We support your drug establishment registration, NDC labeler code request, and drug listing with FDA — mandatory requirements before FDA can issue a CPP for your pharmaceutical products.

Label Compliance Review

Comprehensive review of your drug labels to ensure full compliance with 21 CFR 201 — a critical prerequisite for CPP eligibility. We verify all required labeling elements and correct any deficiencies to meet regulatory standards.

Multi-Country CPP Applications

Streamlined management of CPP applications for multiple importing countries simultaneously — we coordinate submissions, track approvals, and manage the 2-year renewal cycle for all your export markets.

How It Works

We manage the entire process from start to finish — so you can focus on your business.

Eligibility Review

We confirm your drug product and establishment status meets FDA requirements for CPP issuance.

Application Preparation

We prepare your complete CPP application in correct format including all required product and establishment data.

FDA Submission

We submit your CPP application to FDA and manage any queries or requests for additional information.

Certificate Delivery

Upon FDA approval, we deliver the certified CPP to you for use in foreign drug registration.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is a CPP certificate?

A Certificate to a Pharmaceutical Product (CPP) is an official certificate issued by the FDA, confirming that a drug product is authorized for sale in the USA.

Which countries require a CPP?

Many countries in Asia (India, Thailand, Philippines, Vietnam), Africa, Latin America, and the Middle East require a CPP as part of their drug import registration process.

What is the government fee for a CPP?

FDA charges a government fee for CPP applications. LMG charges a separate professional service fee for preparation and submission assistance.

How long does it take to get a CPP from FDA?

FDA typically processes CPP applications within 20 working days of a complete submission. LMG monitors your application and follows up with FDA on your behalf.